Xanmed Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Xanmed Corp.” (first 1984, latest 1987), across 6 product codes in 5 review panels. Median 510(k) review time under this name: 133 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 3 | 3 |
| HBA | Neurosurgical Paddie | 1 | 1 |
| HMP | Pad, Eye | 1 | 1 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 1 | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (3)
- Neurology (1)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
- General and Plastic Surgery (1)
Most recent Xanmed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864623 | OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT | KNA | 1987-01-14 | 50 |
| K844595 | ORTHOPEDIC CUSTOM SURGICAL KIT | LXH | 1985-08-21 | 268 |
| K844596 | EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT | — | 1985-08-01 | 248 |
| K844593 | CARDIOVASCULAR CUSTOM SURGICAL KIT | DYB | 1985-06-21 | 207 |
| K844594 | NEURO CUSTOM SURGICAL KIT | HBA | 1985-06-13 | 199 |
| K851906 | SURGICAL EYE PACK | HMP | 1985-05-21 | 20 |
| K844597 | MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT | — | 1985-04-08 | 133 |
| K843642 | SUBCLAVIAN LEAD INTRODUCER SYS | DYB | 1984-10-23 | 36 |
| K843641 | CATHETER INTRODUCER SYSTEM | DYB | 1984-10-23 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Xanmed Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Xanmed Corp.?
FDA lists 9 510(k) clearances under the applicant name “Xanmed Corp.” (first 1984, latest 1987), across 6 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Xanmed Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xanmed Corp. is 133 days.
Which FDA product codes appear under Xanmed Corp.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 3); HBA (Neurosurgical Paddie, 1); HMP (Pad, Eye, 1).
Next steps
- See all 9 Xanmed Corp. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Xanmed Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.